FDA.reportPublic FDA data

Total Sun Protection

Product NDC
61352-004
11-digit product format
613520004
Labeler code
61352
Product ID
61352-004_43545da6-6e83-7dc3-e063-6294a90ab889
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, Octisalate, Oxybenzone, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Cosmed Dermaceuticals, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-01
Substance
OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE
Active strength
75; 30; 30; 40 mg/g; mg/g; mg/g; mg/g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Total Sun Protection
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/g
OCTISALATE30 mg/g
OXYBENZONE30 mg/g
ZINC OXIDE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbb16ef1-ab8c-4e71-a2a2-a507d104ff0fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61352-004-01Total Sun Protection127.6 g in 1 BOTTLE, PLASTICLOTION127.67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61352-004TOTAL SUN PROTECTION (OCTINOXATE, OCTISALATE, OXYBENZONE, ZINC OXIDE) LOTION [COSMED DERMACEUTICALS, INC.]5Current NDC, Legacy NDC, 1 package rows20241210_dbb16ef1-ab8c-4e71-a2a2-a507d104ff0f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 180 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 IvoryZINC OXIDECosmetic Enterprises Ltd2748c351-0a7d-6913-e063-6394a90a6ef22025-10-13WarningsExact identifier
application number: M020
Impeccable Skin Sunscreen Foundation Broad Spectrum SPF 30 NudeZINC OXIDECosmetic Enterprises Ltd265bd73f-2509-90c6-e063-6294a90a2e192025-10-13WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCdad4b244-2d34-40cb-88dc-991358df83b02025-10-10WarningsExact identifier
application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeafc00ce-12e7-921f-e053-2995a90a241a2025-10-10WarningsExact identifier
application number: M020
KinesysOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc50adf1db-118f-4843-b356-e239931606732025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Performance Sunscreen - Fragrance FreeOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Ince0949325-7de1-4da4-82b6-8004916412a02025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d0294b-e937-336d-e063-6294a90a5c3c2025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Kids Alcohol-Free SunscreenOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc9adea1a4-efa6-4fe1-85e8-ed69fa098a872025-10-10WarningsExact identifier
application number: M020
Kinesys Broad Spectrum SPF 30 Alcohol-Free Sunscreen - Mango ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEWilc Healthcare Inc60e7ed8e-f421-4e08-97a8-af647200e4ae2025-10-10WarningsExact identifier
application number: M020
KINeSYS Pro Sport Lip Balm with Shea Butter Broad Spectrum 30ZINC OXIDEWilc Healthcare Ince5820376-897f-4c77-aadc-7991137870b72025-10-10WarningsExact identifier
application number: M020
KINeSYS Pro Sport Clear Mineral Sunscreen Stick Broad Spectrum SPF45ZINC OXIDEWilc Healthcare Inc247a323f-9a08-4717-8553-ebc9c519817b2025-10-10WarningsExact identifier
application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d15366-85b8-f5e8-e063-6294a90a5fd82025-10-10WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4369f2f-fdc3-e48e-e053-2995a90a07f72025-10-10WarningsExact identifier
application number: M020
Sun Bum Face 50 Premium Sunscreen SPF 50AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4ac746a-a50a-8041-e053-2a95a90a8ea62025-10-10WarningsExact identifier
application number: M020
Wonderscreen Broad Spectrum SPF 30ZINC OXIDEWasatch Product Development, LLC.e895d942-e50e-1ad6-e053-2995a90a0e022025-10-10WarningsExact identifier
application number: M020
Illuminating SPF 50 plus drops Broad Spectrum SunscreenZINC OXIDECosmetic Enterprise Ltd13f40485-b98e-e804-e063-6394a90af2af2025-10-10WarningsExact identifier
application number: M020
Impeccable Skin Moisturizing Face Sunscreen Broad Spectrum SPF 30ZINC OXIDECosmetic Enterprises LTDa84d246b-1153-85ff-e053-2995a90a270a2025-10-10WarningsExact identifier
application number: M020
MediChoice Moisturizing Lip Balm SPF15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEO&M HALYARD, INC.00327815-28f0-4198-bca7-c8ae768ff4162025-10-09WarningsExact identifier
application number: M020
Daybird 4-in-1 Skin Tint SerumZINC OXIDEResette, Inc.19c1a934-b0f5-1068-e063-6294a90a3b1f2025-10-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61352-004-0161352000401127.6 g in 1 BOTTLE, PLASTIC (61352-004-01) 127.6 g2018-02-130000-00-00NoNoCurrent